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Reconfiguring Cardiac Rehabilitation to Achieve Panvascular Prevention: New Care Models for a New World Brief Title: Cardiac Rehabilitation - New Care Models Pratik B. Sandesara, MD a ; Devinder Dhindsa, MD a ; Jay Khambhati, MD a , Suegene K. Lee, MD a ; Tina Varghese, MD a ;; Wesley T. O’Neal, MD, MPH a ; Arash Harzand, MD a ; Dan Gaita, FESC b ; Kornelia Kotseva, MD, PhD, FESC c ; Susan B. Connolly, MB, MRCPI, PhD c ; Catriona Jennings, PhD c ; Sherry L. Grace, PhD, FCCS d ; David A. Wood, MB, ChB, MSc, FRCP c ; Laurence Sperling, MD, FACC, FAHA, FACP, FASPC a a Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GA b Cardiac Rehabilitation Clinic, University of Medicine and Pharmacy, Timisoara, Romania c Department of Cardiovascular Medicine, National Heart and Lung Institute, Imperial College London, London, UK d School of Kinesiology and Health Science, York University, Toronto, Canada; University Health Network, University of Toronto, Canada Word Count: Figures: 2 figures Funding PBS is supported by the Abraham J. & Phyllis Katz Foundation (Atlanta, GA) Disclosures Dr. Harzand reports consulting for, being a minor investor in, and participating in a speaker’s bureau with Moving Analytics, Inc. 1

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Page 1: spiral.imperial.ac.uk · Web viewWord Count: Figures: 2 figures Funding PBS is supported by the Abraham J. & Phyllis Katz Foundation (Atlanta, GA) Disclosures Dr. Harzand reports

Reconfiguring Cardiac Rehabilitation to Achieve Panvascular Prevention:

New Care Models for a New World

Brief Title: Cardiac Rehabilitation - New Care Models

Pratik B. Sandesara, MDa; Devinder Dhindsa, MDa; Jay Khambhati, MDa , Suegene K. Lee, MDa; Tina Varghese, MDa;; Wesley T. O’Neal, MD, MPHa; Arash Harzand, MDa; Dan Gaita, FESCb; Kornelia Kotseva, MD, PhD, FESCc; Susan B. Connolly, MB, MRCPI, PhDc; Catriona

Jennings, PhDc; Sherry L. Grace, PhD, FCCSd; David A. Wood, MB, ChB, MSc, FRCPc; Laurence Sperling, MD, FACC, FAHA, FACP, FASPCa

aDivision of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GAbCardiac Rehabilitation Clinic, University of Medicine and Pharmacy, Timisoara, RomaniacDepartment of Cardiovascular Medicine, National Heart and Lung Institute, Imperial College London, London, UKdSchool of Kinesiology and Health Science, York University, Toronto, Canada; University Health Network, University of Toronto, Canada

Word Count:

Figures: 2 figures

Funding

PBS is supported by the Abraham J. & Phyllis Katz Foundation (Atlanta, GA)

Disclosures

Dr. Harzand reports consulting for, being a minor investor in, and participating in a speaker’s bureau with Moving Analytics, Inc.

None for the other co-authors

Address for correspondenceLaurence Sperling, MD, FACC, FAHA, FACP, FASPC1365 Clifton Road, NEBuilding A, Suite 2200Atlanta, GA 30322Tel: (404) 778-2746 Fax: (404) 778-2895E-mail: [email protected]

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Abstract

Atherosclerotic cardiovascular disease (ASCVD) and its associated economic burden is

increasing globally. Although cardiac rehabilitation (CR) is an important component of

secondary prevention with proven benefits, it is underutilized due to numerous barriers,

especially in resource-limited settings. New care models for delivery of comprehensive

prevention programs such as community-based, home-based, and “hybrid” models implementing

m-health, e-health, and telemedicine need to be adopted. Such new care models should be

offered to all patients with established ASCVD (coronary, cerebral and peripheral) and

additionally to those at high risk of developing ASCVD with multiple risk factors for

panvascular prevention.

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Introduction

The epidemic of atherosclerotic cardiovascular diseases (ASCVD) is growing globally,

with an estimated prevalence of more than 100 million and projected economic burden of

approximately $15 trillion over the next 20 years 1, 2. This increasing burden is due to the growth

of ASCVD in low- and middle-income countries (LMICs) together with demographic changes

and an increasing prevalence of obesity, metabolic syndrome and diabetes 3.

With regard to the former, the rates of major ASCVD events and ASCVD-related

mortality were found to be substantially higher in LMICs than in high-income countries (HICs),

despite a lower traditional cardiovascular risk factor burden in LMICs 4. Even more striking is

the low rate of secondary prevention, such as medication use (i.e., anti-platelet agents, beta-

blockers, angiotensin converting enzyme inhibitors [ACE-I] or angiotensin-II receptor blockers

[ARBs], and statins). In the poorest countries, 80% of the population with reported ASCVD is

not on any medical therapy, compared to 11% in HICs 5. Additionally, low rates of lifestyle

changes in individuals with ASCVD are particularly evident in the LMICs, namely non-

adherence to a heart-healthy diet, physical inactivity and suboptimal rates of smoking cessation 6.

Despite the improved efficacy of current therapeutic interventions, delivery to and

implementation of these in populations in need of them pose a major challenge. Comprehensive

prevention programs provide an avenue by which this barrier can be overcome. Cardiac

rehabilitation (CR) is a model of care that provides comprehensive service including medical

evaluation, prescriptive exercise, cardiac risk factor modification, education, and psychosocial

counseling; it is the cornerstone for secondary prevention of ASCVD and an essential component

to achieve global targets set by the WHO 25x25 initiative 1, 7.

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These prevention programs favorably influence underlying CV risk factors and associated

mortality, which are essential for stemming the growing global epidemic of ASCVD. However,

these programs continue to be under-utilized, particularly in resource-limited settings. Therefore,

in this review, we discuss the benefits of CR, current realities and barriers to CR utilization, and

highlight new care models for improved delivery of this impactful intervention for ASCVD

prevention.

Indications and Benefits of Cardiac Rehabilitation

CR is a class IA indication and CR referral a quality of care metric following acute

coronary syndrome (ACS), chronic stable angina, coronary artery bypass graft surgery (CABG),

percutaneous coronary intervention (PCI), and systolic heart failure according to the American

Heart Association (AHA), American College of Cardiology (ACC) and European Society of

Cardiology guidelines 8-15, among others. CR is also indicated for patients following valve

procedures or cardiac transplantation 9, 16. More recently, for patients with peripheral artery

disease (PAD) and claudication, a supervised exercise program is classified as a class IA

recommendation by the ACC/AHA guidelines 17. Additionally, there has been evidence that CR

has shown benefit following stroke in reducing the risk of future cardiovascular events and

improving functional status 18, 19.

The benefits of CR for secondary prevention of coronary artery disease (CAD) are

compelling and well-established. A Cochrane systematic review and meta-analysis of

randomized controlled trials involving 14,486 patients with myocardial infarction (MI), angina,

or coronary revascularization demonstrated reductions in cardiovascular (CV) mortality by 26%

and hospital readmissions by 18%, as well as improvements in many quality of life measures in

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those that completed CR compared to usual care 20. CR is also shown to be cost-effective,

affordable, and to avert downstream healthcare utilization 21, 22.

Current Realities as well as Barriers to CR Referral and Delivery

Current CR delivery model

There is wide variation in CR delivery guidelines in countries around the world 23, though

there is broad consensus regarding the core components of CR as outlined in the International

Council of Cardiovascular Prevention and Rehabilitation (ICCPR) consensus guidelines

endorsed by 10 major national/international cardiac societies. These core components include

(1) assessment, (2) lifestyle risk factor management (i.e. physical activity, diet, tobacco and

mental health), (3) medical risk factor management (e.g. lipid control, blood pressure (BP)

control), (4) education for self-management and (5) return to work 24. Within these guidelines,

there is room for substantial variation in practice.

In the US for example, CR generally consists of up to 36 outpatient sessions over a span

of 8-12 weeks, delivered in electrocardiogram (ECG)-monitored settings 25. The dose varies

broadly however globally.26 Additionally, there is a variation in opinion regarding whether a

physician is required to lead a CR program. In some European countries, CR is delivered in

residential “spa” settings, and in the community in some low-resource settings. However,

globally most CR programs are delivered in supervised settings in tertiary care centers, which

likely contribute to the higher costs of these programs.

CR Under-Utilization

On a global basis, CR remains underutilized. A survey from EUROASPIRE III across 76

centers in 22 European countries also showed low referral (45%) and participation (37%) rates in

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patients with coronary heart disease 27. A recent study found that only 14-35% of patients who

had an MI and 31% of patients after CABG participate in CR 9. Of 58,269 patients eligible for

CR after an MI, only 62.4% were referred at the time of hospital discharge, with only 32.6% of

those referred attending at least 1 session within the next year and only 5.4% completing 36

sessions 28. Fewer than 50% of eligible patients are referred to CR globally 3. In particular, most

LMICs have a CR referral rate of <40% and the most commonly cited barrier was a lack of

physician referral 2. Recent meta-analyses suggest referral rates of 43% 29, enrolment rates of

42% 30, and overall adherence to 66% of sessions in those enrolling 31.

Barriers to CR are multi-level including physician/provider, patient and system related-

factors (Figure 1). With regard to the former, in the above study inpatient referral was a strong

predictor of eventual CR participation (odds ratio [OR] 12.16, 95% CI 5.50-26.89) but

physicians tend to under-refer certain sub-populations (women, ethnic minorities, heart failure

patients) despite clear indications 29, 32-35, highlighting the need for system-level interventions to

reduce inequity and referral barriers. CR referral rates are persistently sub-optimal, despite

guideline recommendations for referral based on the proven benefits (both summarized above).

Of the many barriers to participation in CR, lack of initial referral by physicians is a correctable

obstacle to subsequent enrollment of patients in CR.

Participation in CR is low even where patients are referred. Thus, the low participation

rate stems from not only low referral rates, but also low patient enrollment, and subsequent

program completion 7. Patient-specific barriers to CR participation include activity-limiting

comorbid conditions, low motivation / lack of awareness, geographic inaccessibility, competing

domestic or vocational responsibilities. Moreover, women are less likely to complete CR 36.

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Lower socioeconomic status and geography (i.e. rural populations) have also been shown to be

associated with decreased likelihood of completing a course of CR 37.

The current model of CR has significant obstacles to financial viability because it is not

reimbursed like other cardiac services-- pointing to a need for change on a systems-level. CR

payers are inconsistent around the globe 38, 39. Many patients pay out-of-pocket for CR and find it

financially difficult to afford. Furthermore, the revenues of traditional center-based CR programs

are often insufficient to meet their delivery costs 40.

The limited number of CR programs is also a key system-level barrier globally. To date,

only 38.8% of the countries worldwide have any CR programs3, despite its proven benefits as an

essential mechanism for secondary prevention. The Carinex Survey and the European Cardiac

Rehabilitation Inventory Survey found that of the 75 HICs, only 51 (68%) had CR services

available 3, 41, 42. Of greater concern is the lower availability of CR in middle-income (28.2%) and

low-income (8.3%) countries where >80% of ASCVD deaths occur 3, 39, 43.The density of CR

programs (number of CR programs per inhabitant) is low globally, but is also significantly lower

in LMICs. The US has the highest CR program density in the world with one program per

102,000 inhabitants, whereas some LMICs have as few as one program per 160 million

inhabitants 3.

Roadblocks and care gaps in low and middle-income countries specifically

The discrepancy between best evidence-based clinical practice and the actual care

provided is referred to as the “care gap.” Although care gaps can be seen in all countries, they are

most severe in LMICs and rural settings due to limited resources 1. The Population Urban Rural

Epidemiology (PURE) cohort study reported that ASCVD patients in LMICs had the lowest

rates of lifestyle changes, including adherence to a heart-healthy diet, physical activity, and

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tobacco cessation 5, 6. The more pronounced care gaps in these countries are secondary to lower

rates of preventive care, lower healthcare, inadequate care of patients with acute CV events

(often due to lack of coverage and availability of public services), and poor chronic management

of people with ASCVD 22. Limited access to care, including health services and medications,

and low health literacy are possible contributing factors as well. Thus, use of CR worldwide,

including in HICs, is suboptimal due to numerous barriers outlined herein, and new care models

are needed to overcome these barriers.

New Care Models / Settings

As outlined above, most CR is delivered in supervised settings, and we have grossly

insufficient reach. To address the issue of CR underutilization, alternative models have been

established to improve patient uptake, choice, and access 44. When asked about barriers to

accepting a referral, patients often cite concerns such as accessibility and transportation, a

reluctance to participate in a group setting, and work or domestic commitments 45-47. Moreover,

delivery of CR in alternative settings could greatly increase capacity. CR should increasingly be

offered in the home and community and exploit existing primary care services and information

and communications technologies.

Home-based programs

One model that addresses these issues directly is a regimen in which patients can

participate from their home on a more flexible schedule without having to travel to a dedicated

CR center. The home-based model also consists of all core CR components, but they are

delivered through regular contact with staff through telephone calls and/or other technology, as

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well as self-monitoring diaries for heart-healthy behaviors 48. It may also include remote

monitoring. An example of an evidence-based standardized model is the Heart Manual 49.

Home-based CR has been shown to be safe, cost-effective, and as effective as a center-

based rehabilitation program, making it an attractive option for enhancing CR utilization,

particularly for low to intermediate-risk patients 50, 51. A meta-analysis of available studies on

home- vs. center-based CR demonstrated not only the efficacy, but also a comparable, if not

higher completion rate as compared to center-based CR 52.

Community-based programs

Community-based CR programs are effective alternatives to traditional center-based

models of CR delivery 50. Community-based programs utilize alternative care models including

multifactorial individualized telehealth, an internet-based regimen, and home-based therapies 50.

Importantly, these modalities, namely multifactorial individualized telehealth and home-based

CR have shown comparable risk factor reductions as compared to hospital-based CR regimens 53,

54.

The MyAction Program developed in Europe offers an innovative, community-based

prevention program 55. MyAction represents an evolution of EUROACTION, a cluster

randomized-controlled trial of a nurse-coordinated multidisciplinary, family-based ASCVD

prevention program that was conducted in hospitals and general practice across eight European

countries 56. The program used a behavioral approach to address lifestyle, together with medical

risk factor management and the use of cardio-protective medications. At one year, the program

demonstrated healthier lifestyle changes and improvements in other risk factors for patients with

coronary heart disease and those at high risk of ASCVD and their partners than those in usual

care. The program subsequently evolved in the United Kingdom (UK) through integration of

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secondary and primary prevention in one community-based ASCVD panvascular prevention

program called MyAction. The feasibility of this approach has now been demonstrated in 2

different healthcare settings – both in London in a socioeconomically and ethnically diverse

population and also in Galway in the West of Ireland with outcomes that are similar, or even

better than the EUROACTION trial 55, 57.

This model involves integrative secondary prevention for patients with ASCVD and

high-risk primary prevention for patients with multiple ASCVD risk factors by focusing on

comprehensive lifestyle modifications and medical therapy to achieve optimal risk factor control.

This community-based, nurse-led, physician supervised 12-week program is delivered by a

multi-disciplinary team including nurses, dietitians, physical activity specialists, and clinical

psychologists. Patients and their partners undergo initial assessment of their lifestyle and risk

factors which informs an individualized care plan incorporating behavioral change strategies,

education and exercise. The comprehensive approach includes support for smoking cessation,

healthy eating, physical activity in everyday living, weight management, risk factor control, and

prescribing cardio-protective drugs .The efficacy of the MyAction program was demonstrated in

a study of 3232 patients 55. Significant improvements in healthy living, such as adherence to a

cardio-protective diet and increased physical activity were observed and maintained over a one-

year follow-up. Improvements in medical risk factors (blood pressure and lipids), prescription of,

and adherence to cardioprotective medications were also seen. Patient-reported outcomes such as

depression and quality of life improved as well.

Furthermore, the RESPONSE 2 (Randomized Evaluation of Secondary Prevention by

Outpatient Nurse Specialists 2) trial showed that community-based lifestyle programs are

effective in improving lifestyle risk factors (weight loss, physical activity and smoking cessation)

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in patients with CAD compared to usual care alone 58. These types of community-based

programs could be successfully adopted and implemented as an alternative to traditional, center-

based CR, as a multi-faceted approach to primary and secondary ASCVD prevention. Going

forward, however, more data is needed regarding the cost-effectiveness of these models.

Consideration also is needed for liability and coverage for the healthcare providers delivering the

care.

eCR programs

Efforts to augment this home-based care with information and communication

technologies, often termed telehealth CR, has provided enhanced, additional opportunity for

counselling, education, and feedback 51. For example, one phone call every four weeks using

telephonic coaching in the ‘Hartcoach’ Trial in the Netherlands, demonstrated a modest impact

on body composition, physical activity and vegetable intake in patients with ASCVD over the 6-

month study period 59. In their review, Rawstorn et al. noted an improvement in physical activity,

diastolic blood pressure, and lipids with telehealth CR as compared to a center-based program 51.

This “hybrid” model of telehealth serves to augment usual home-based CR, and functions as an

attractive option going forward for increased reach of CR.

The increasing use of mobile technology in developing countries, serves as an

opportunity to reduce gaps in access for CR, through so-called mobile health or “M-health”. The

penetrance of mobile technology is increasing globally, and already the penetration rate is 90%

in LMICs, increased from 45% of the population in LICs in 2011, and 75% in LMICs during that

time 56, 60. In the U.S., approximately 95% of adults own a cellphone of some kind, with

smartphone ownership estimated to be at 77%, an increase from 35% in 2011. This rise in

smartphone adoption provides an opportunity to leverage additional advances in mobile

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computing such as task automation, higher fidelity data regarding patient behaviors and physical

activity, and enhanced two-way communication. Early research suggests “mCR” may be

associated with greater utilization. Specifically, post-MI patients assigned to a smartphone-based

CR program were shown to have greater uptake (80% vs 62%), adherence (94% vs 68%), and

completion (80% vs 47%) compared to those assigned to traditional, center-based CR 61.

Importantly, both groups showed significant and comparable improvements in physiological and

psychological outcomes. This suggests equivalent benefits may be achieved, and potential

reductions in mortality and morbidity commensurate with those observed with center-based

programs, but with much greater reach.

Furthermore, the utility of m-health also extends to text-message reminders supporting

the promotion of healthy behavior modification 62, 63. Data supporting the efficacy of this low-

cost intervention is demonstrated in a study in which patients enrolled in an outpatient CR

program were to receive three to five text message reminders per week reminding them of heart-

healthy tips, medication adherence, as well as assessment and reporting of body weight, minutes

of exercise, and blood pressure. With just the addition of these text message reminders, there

was a significant difference in attendance of sessions and completion of the program 64.

Similarly, the randomized controlled Tobacco, Exercise and Diet Messages (TEXT ME) trial

showed that the use of lifestyle-focused text messaging resulted in significant reduction in low

density lipoprotein cholesterol, systolic blood pressure, body mass index, smoking rates and an

increase in physical activity compared to usual care in patients with ASCVD 65.

In general, systematic reviews of the literature do indicate a benefit of digital health

interventions (telemedicine, web-based strategies, e-mail, mobile applications, text messages,

remote monitoring) on attenuating ASCVD risk. These may provide an important low-cost and

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readily available tool for addressing the global burden of ASCVD 66. An important area of future

investigation will be exploring opportunities to optimize other emerging technologies (i.e.

smartphone applications), to improve access, reach and effectiveness of CR.

Model for low-resource settings

Overall, as an alternative to traditional center-based CR programs, these new care

prevention and rehabilitation models / settings can be adopted in both HICs and LMICs to

improve suboptimal utilization rates and overcome barriers. LMICs face unique barriers due to

scarcity of resources and therefore, new care models for secondary prevention programs tailored

specifically for low-resource settings (i.e., LMIC and under-resource areas in HICs) have been

proposed by an International Council of Cardiovascular Prevention and Rehabilitation (ICCPR)

consensus statement. This statement proposes strategies to deliver each of the core CR

components (i.e., risk assessment, lifestyle risk factor management, medical risk factor

management, education, and return to work) using the fewest resources possible 67. This model is

based on a nurse/allied health or community health worker led program, delivered in non-clinical

settings to minimize cost. As emphasized in the consensus statement, consideration of health

literacy, gender, religion and cultural context in the care delivery model is imperative. Limited

equipment for exercise and monitoring adds to the challenge of providing CR services in low-

resource settings and therefore, exercise programs requiring no equipment, such as walking,

provide a practical alternative. When possible, low-cost options such as resistance bands,

pedometers, and “home-made” weights can be utilized. These services can be delivered in the

community at places such as schools, places of worship or local meeting places to minimize

costs. This model can also be adopted in under-resourced areas in HICs to expand CR delivery

and overcome barriers related to cost.

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Risk assessment and stratification should be the starting point for selection of appropriate

level of supervision needed in order to tailor CR programs to meet individual patient needs and

risk factor interventions 68. Figure 2 provides a framework for CR delivery where resource

intensity is tailored to individual risk level. Hybrid models could be used, where high-risk

patients commence in supervised settings, and transition to unsupervised settings (potentially

including new technologies) once safety has been established.

Future Directions

Panvascular Prevention – The Case for Change

Patients with established ASCVD are at increased risk for recurrent CV events. This not

only applies to coronary patients but also to those with cerebrovascular disease and PAD. Yet,

the care of these patients is frequently delivered in silos by neurology, cardiology and vascular

services. While such a disease-specific approach may be appropriate for acute treatment, it is less

so for prevention as many patients have overlapping risk factors and diffuse overt vascular

disease occurs in at least 20% of patients 69. Furthermore, the REduction of Atherothrombosis for

Continued Health (REACH) registry has shown that those with cerebrovascular disease and PAD

have an even higher hard ASCVD event rate (MI/cerebrovascular accident (CVA)/death) at 3

years than those with coronary heart disease. Patients with cerebrovascular disease and PAD will

likely benefit from the same comprehensive CV risk reduction approaches while the exercise

prescription could be tailored to accommodate physical limitations and disabilities 70.

There is a large treatment gap, particularly for patients with PAD, where studies have

consistently demonstrated concerning underuse of preventive therapies such as statins and anti-

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platelet drugs, with only a minority receiving lifestyle counselling 71, 72. All patients with

established ASCVD merit access to a professional lifestyle and risk factor intervention program

to reduce their risk of a recurrent CV event and improve their quality of life.

Furthermore, asymptomatic patients with multiple risk factors are often at higher risk for

ASCVD. Therefore, we need to address a continuum of risk from secondary through primary

prevention and deliver these comprehensive prevention programs to those at increased risk. The

definition of panvascular prevention should include those with CAD, cerebrovascular disease,

PAD and the asymptomatic high-risk population. These patients could be managed within a

multi-faceted preventive cardiology program.

Conclusion

The growing burden of ASCVD in LMICs together with the increasing prevalence of

obesity, metabolic syndrome, and diabetes in HICs pose a significant threat to CV health

globally. The implementation of effective prevention strategies for individuals with ASCVD is

needed to reduce morbidity and mortality. New care models for comprehensive risk reduction

programs including community-based, home-based, and “hybrid” models utilizing m-health, e-

health, and telemedicine need to be implemented. These programs should be implemented not

only for patients with established ASCVD, but also for patients with multiple risk factors who

are at high ASCVD risk, embracing panvascular prevention.

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Figure Legends

Figure 1: Strategies to Overcome Cardiac Rehabilitation Referral, Enrollment and

Adherence/Completion Barriers

Patient, provider and health systems related barriers contribute to inadequate utilization of CR.

The table on the right provides potential solutions to overcome these barriers to referral,

enrollment and adherence/completion of CR programs. EMR=electronic medical record; CR =

Cardiac Rehabilitation

Figure 2: Three Levels of Resource Intensity Based on Patient Risk Level

This figure provides a framework for CR delivery and resource intensity based on individual risk

level. CR = Cardiac Rehabilitation

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Figure 1

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Figure 2

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